FS-67 in the Treatment of Pediatric Patients With Ankle Sprain

Phase 4

Completed

• Conditions: Ankle Sprain
• Interventions: Drug: FS-67 Patch; Other: Placebo Patch

• Registration Number: NCT01037816
• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Brief Summary

The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

Detailed Description

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Disposition First Submitted: 2015-03-17
• Disposition First Submitted QC: 2015-05-12
• Disposition First Posted: 2015-06-04
• Results First Submitted: 2020-09-04
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Results First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Grade 1 or Grade 2 ankle sprain

Exclusion Criteria

• Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FS-67 patch	FS-67 Patch	One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Placebo Patch	Placebo Patch	One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Primary Outcome Measures

Name	Time	Method
Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.	8 hours of patch application on Day 1	Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.

Secondary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.	8 hours of patch application on Day 1	Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) at rest observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.

Trial Locations

Locations (1)

Hisamitsu Investigator Site; 🇺🇸 Grapevine, Texas, United States